drugset / Trial / NCT01439282

Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer

NCT01439282

Phase 2 Completed 77 enrolled Eisai Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 2, multicenter, single-arm, feasibility study evaluating eribulin in combination with capecitabine as an adjuvant chemotherapy regimen in approximately 65 subjects with early-stage (I-II), human epidermal growth factor receptor 2 (HER2)- normal, estrogen receptor (ER)-positive breast cancer.

Timeline

Start
2011-08
Primary completion
2012-11
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 900 mg/m2 Oral
Subject Capecitabine Small molecule 1500 mg Oral
Subject Eribulin Small molecule 1.4 mg/m2 Intravenous